Clinical trials: Surgical Performance
Chronic Sinusitis
Safety and Performance of the Steroid-Releasing S8 Sinus Implant
The purpose of this study was to assess the safety and performance of the steroid-releasing S8 Sinus Implant when used in post-sinus surgery patients who presented with recurrent sinus obstruction.
- Trial name
- S8PK (NCT01894503)
- Testing
- S8 Sinus Implant (mometasone furoate, 1350 mcg)
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Intersect ENT
Cataract
Evaluate Performance of Callisto Eye vs. Wavetec AnalyzOR
The goal of this clinical trial is to evaluate two separate operating room cataract measuring tools in predicting the residual astigmatism (prediction error) in patients with corneal astigmatism.
- Trial name
- CORTCO (NCT06216067)
- Testing
- CALLISTO eye, Wavetec AnalyzOR
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Chesapeake Eyecare and Laser Center, LLC
Cataract
Post-Implant Performance of the EC-3 IOL
The purpose of this study is to obtain data on the performance of the EC-3 lens at an interval of two years (and beyond) from subjects who were implanted.
- Trial name
- NCT01333345
- Where
- 3 sites in United States, France
- Volunteers
- 100 people
- Sponsor
- Aaren Scientific Inc.
Cerebrospinal Fluid Leak
Evaluate the Safety and Performance of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery
The objective of the study is to clinically assess the safety and performance of the Dura Sealant Patch as a means of reducing intra- as well as post-operative CSF leakage in patients undergoing elective cranial intradural…
- Trial name
- NCT03566602
- Testing
- Dura Sealant Patch
- Where
- 3 sites in Netherlands, Switzerland
- Volunteers
- 40 people
- Sponsor
- Polyganics BV
Myoma
Safety and Efficacy Study of a Hydrogel, Applied Following Removal of Myomas During Gynecologic Surgery, Administered for the Prevention/Reduction of Postoperative Adhesion Formation
The purpose of this study was to determine whether the adhesion prevention gel was safe to use, and was effective for the prevention/reduction of adhesion formation that typically occurs following gynecological surgery to remove…
- Trial name
- NCT00562471
- Testing
- Adhibit Adhesion Prevention Gel, Standard of Care Comparator
- Where
- 6 sites in Canada, Germany and 1 more
- Volunteers
- 76 people
- Sponsor
- Angiotech Pharmaceuticals
Pelvic Organ Prolapse
Performance of Tension Free Vaginal Mesh (Prolift) Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse.
Pelvic organ prolapse is a common problem. A lot of women have surgery for prolapse. The recurrence rate op pelvic organ prolapse after surgical treatment is high.
- Trial name
- NCT00372190
- Testing
- Tensionfree vaginal mesh kit (Prolift), classic vaginal prolapse surgery (fascia plication)
- Where
- 13 sites in Netherlands
- Volunteers
- 194 people
- Sponsor
- Radboud University Medical Center
Breast Cancer, Neoadjuvant Therapy
Feasibility Study of Intraoperative Detection of Residual Cancer in Breast Cancer Patients
This is a prospective, multi-center, randomized, clinical trial evaluating patients undergoing breast conserving surgery using the LUM Imaging System.
- Trial name
- NCT04440982
- Testing
- LUM015, Lum Imaging System
- Where
- 6 sites in United States
- Volunteers
- 98 people
- Sponsor
- Lumicell, Inc.
Cardiac Valve Disease
Ultrafiltration on Coagulation Performance in Cardiac Surgery
In cardiac surgery patients with CPB-induced dilutional coagulopathy, ultrafiltration (UF) was applied to reduce free water and concentrate all blood components before the weaning from CPB.
- Trial name
- NCT05252559
- Testing
- ultrafiltration, maximal clot firmness in EXTEM assay of ROTEM test
- Where
- South Korea
- Volunteers
- 75 people
- Sponsor
- Konkuk University Medical Center
Foot Diseases
Study to Evaluate Safety, of NextraTM in Surgery to Fuse the Proximal-interphalangeal- Joints
Hammertoe deformity is the most common deformity of the lesser toes. It primarily comprises flexion deformity of the proximal interphalangeal (PIP) joint of the toe, with hyperextension of the metatarsophalangeal (MTP).
- Trial name
- NCT01604070
- Where
- 4 sites in United States
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- eMedtrain Inc.
Mitral Regurgitation, Mitral Insufficiency
5-Year Follow-Up Safety and Performance Evaluation of the Medtentia Annuloplasty Ring in Adults
Single-center clinical investigation is to evaluate long-term safety and performance of the Medtentia Annuloplasty Ring (MAR) in 11 patients who underwent successful mitral valve (MV) surgery using Medtentia's MAR system in…
- Trial name
- NCT04161079
- Testing
- Medtentia Annuloplasty Ring (MAR)
- Where
- Finland
- Volunteers
- 12 people
- Sponsor
- Medtentia International Ltd Oy
Oral Hemorrhage
Performance and Safety of the Surgical Hemostatic Agent "HEMOCOLLAGENE®" in Patients Requiring Oral Surgery
The aim of this study is to collect performance and safety data relating to the use and the follow-up of the HEMOCOLLAGENE® medical device in routine clinical practice from various hospitals and medical centers in oral dental…
- Trial name
- NCT05171231
- Testing
- HEMOCOLLAGENE® : Sterile absorbable hemostatic sponges based on bovine collagen - class III MD
- Where
- 10 sites in Belgium, France
- Volunteers
- 125 people
- Sponsor
- Septodont
Cardiac Output, Low, Cardiac Output, High
Continous Cardiac Output - Non-Invasive Evaluation (CONNIE)
The capnodynamic method non-invasively calculates effective pulmonary blood flow (EPBF) continuously during surgery. In this study EPBF is compared to cardiac output (CO) measured with Transpulmonary Thermodilution (TPTD) att…
- Trial name
- CONNIE (NCT03444545)
- Testing
- Capnodynamic method, Transpulmonary thermodilution
- Where
- Sweden
- Volunteers
- 35 people
- Sponsor
- Karolinska Institutet
Twin to Twin Transfusion Syndrome, Congenital Diaphragmatic Hernia
Automated Myocardial Performance Index Using Samsung HERA W10
Researchers are using Myocardial performance index (MPI) to assess fetal cardiac function before, during, and after fetal surgery in order to gain more knowledge about fetal cardiac function in high risk pregnancies and the…
- Conditions
- Twin to Twin Transfusion Syndrome, Congenital Diaphragmatic Hernia, Neural Tube Defects, Lower Urinary Tract Infection
- Trial name
- NCT04140669
- Testing
- Automated Myocardial Performance Index (MPI)
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Mayo Clinic
Hemorrhage, Blood Loss
Clinical Investigation Evaluating a New Autotransfusion Device in Cardiac Surgery
Blood transfusion is at the heart of the therapeutic arsenal when there is a hemorrhage and/or blood loss during a surgery. There are two types of transfusion: the homologous one (blood from a compatible donor) and the autologous…
- Conditions
- Hemorrhage, Blood Loss, Surgical Blood Loss
- Trial name
- i-TRANSEP (NCT04588350)
- Testing
- i-SEP autotransfusion system
- Where
- 5 sites in France
- Volunteers
- 50 people
- Sponsor
- i-SEP
Diabetic Ulcers, Arterial Ulcers
Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds
The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Debrisoft® Duo, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated…
- Conditions
- Diabetic Ulcers, Arterial Ulcers, Venous Ulcers, Pressure Ulcers
- Trial name
- NCT07312513
- Testing
- two sided debridement pad, one sided debridment pad
- Where
- 5 sites in Poland
- Volunteers
- 100 people
- Sponsor
- Lohmann & Rauscher
Arterial Thromboembolism
A PMCF Study to Confirm the Performance and Safety of the LeMaitre® TufTex Single Lumen Embolectomy Catheter
A post market clinical study to confirm the performance and safety of the LeMaitre® TufTex Single Lumen Embolectomy Catheter on patients undergoing surgical treatment for the removal of arterial emboli and/or thrombi
- Trial name
- SLC (NCT05386277)
- Testing
- TufTex Single Lumen Embolectomy Catheter
- Where
- 3 sites in Belgium, Germany and 1 more
- Volunteers
- 112 people
- Sponsor
- LeMaitre Vascular
Sport Surgery
Sport Surgery Products Outcomes - A Post-market Follow-up
Teknimed is currently conducting a post-market clinical follow-up which will confirm performance, safety and usability for all the Teknimed range of Sports products.
- Trial name
- NCT06532929
- Testing
- Orthopaedic surgeries (ankle), Orthopaedic surgeries (shoulder), Orthopaedic surgeries (knee)
- Where
- 10 sites in France
- Volunteers
- 390 people
- Sponsor
- Teknimed
Anterior Cruciate Ligament Rupture
Efficacy of Preoperative Re-education on Patients With an Anterior Cruciate Ligament Rupture
Anterior cruciate ligament (ACR) rupture is a common lesion of sportsmen that leads to functional deficits which are difficult to overcome.
- Trial name
- PRELIG (NCT02505659)
- Testing
- Preoperative re-education
- Where
- France
- Volunteers
- 80 people
- Sponsor
- University Hospital, Clermont-Ferrand
Cholecystectomy, Robotic
Post Market Clinical Study to Evaluate the Performance of the Versius Surgical System
The goal of this clinical trial is to learn how the Versius Surgical System, a robotic surgery device, works for gallbladder removal surgery (cholecystectomy) in adults.
- Trial name
- NCT07096856
- Testing
- Robotic assisted cholecystectomy
- Where
- 3 sites in United States
- Volunteers
- 100 people
- Sponsor
- CMR Surgical Ltd
Performance of Wrong Procedure (Operation)
Trial on Laparoscopic Simulation Based on Mentoring
More than 50 residents in surgical specialities (OB\&G, General surgery and Urology) from a single university in Italy will be randomized into two groups, after a stratification based on residency year and laparoscopic/simulator…
- Trial name
- NCT02486575
- Testing
- Self-learning, Mentoring
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Università degli Studi di Brescia